This early phase I trial tests the safety, side effects, and effectiveness of adaptive, individualized dose increase (escalation) of the fluorouracil and oxaliplatin (FOX) regimen in treating patients with gastrointestinal cancer that has spread from where it first started (primary site) to other places in the body (metastatic), has spread to nearby tissue or lymph nodes (locally advanced), or cannot be removed by surgery (inoperable). Gastrointestinal cancer includes cancer of the colon, rectum, esophagus, stomach, or other gastrointestinal organs. The usual approach to treat gastrointestinal cancer uses leucovorin and height and weight-based doses of the FOX chemotherapy medications. Chemotherapy drugs, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This regimen can reduce cancer-related symptoms, may stop cancer from growing for a few months or longer, and help patients with gastrointestinal cancer live longer. FOX dose adjustments in usual care go down only, and often are not done in the same way for all people. Information gained from this study may allow researchers to determine whether customized dose adjustments of the FOX regimen, whether up and down in a specific way according to a person's blood test results and side effects is better than, worse than, or similar to usual care in treating patients with metastatic or locally advanced/inoperable gastrointestinal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05780684.
Locations matching your search criteria
United States
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterStatus: Active
Contact: Gabriel Arne Brooks
Phone: 603-650-9474
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of the FOX regimen (oxaliplatin and adaptively dose-escalated infusional 5-fluorouracil [5-FU]) for advanced gastrointestinal cancer.
SECONDARY AND CORRELATIVE OBJECTIVES:
I. To evaluate the preliminary efficacy of the FOX regimen.
II. To evaluate the relative dose intensity of the FOX regimen in patients managed according to the investigational dose escalation algorithm.
III. To assess the safety and tolerability of the FOX regimen as measured by occurrence of adverse effects.
IV. To evaluate the relationship between baseline plasma uracil concentration and receipt of dose-intensified infusional 5-FU.
V. To evaluate 5-FU drug exposure (5-FU area under the curve [AUC]) after completion of 5-FU dose titration.
OUTLINE:
CYCLE 1: Patients receive fluorouracil intravenously (IV) over 46 hours, oxaliplatin IV, and leucovorin IV on day 1 in the absence of disease progression or unacceptable toxicity.
CYCLES 2-4: Patients receive fluorouracil IV over 46 hours at an increased, decreased, or continued dose as cycle 1, oxaliplatin IV, and leucovorin IV on day 1 of each cycle. Cycles 2-4 repeat every 14 days in the absence of disease progression or unacceptable toxicity.
CYCLES 5+: Patients receive fluorouracil IV over 46 hours at a continued or decreased dose, oxaliplatin IV, and leucovorin IV on day 1 of each cycle. Cycles repeat every 14 days for a total of 6 months from cycle 1 in the absence of disease progression or unacceptable toxicity.
Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) as well as blood sample collection during screening and on study.
After completion of study treatment, patients are followed up at 30 days.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorGabriel Arne Brooks
